Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
NCT Number: NCT05040685
The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.
A significant decrease of lymphedema rates in patients who was possible associate ARM technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques like fluorescence dye.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Axillary lymph node dissection (ALND) was the standard therapy until 1990-2000, when the technique was replaced, when possible, by another procedure associated with less morbidity: the sentinel lymph node biopsy (SLNB). However, actually, ALND is still the gold standard in some patients. This procedure is associated with substantial morbidity, like lymphedema, shoulder pain, arm numbness, axillary web syndrome and decreased upper-extremity range of motion (ROM), that severely conditions the quality of life of these patients.
In 2007, the investigators had the first reports about a new surgical technique, the axillary mapping reverse (ARM), that consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.
The current literature shows a significant decrease of lymphedema rates in patients who was possible associate this technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques. With the use of indocyanine green, the visualisation rates in the axilla of ARM lymphatics are from 88%, similar to other techniques. Some advantages of fluorescence dye are that no systemic allergic reactions have been reported and the 'green tattoo' disappears quickly.
HYPHOTESIS The axillary mapping reverse (AMR) is able to identify the lymph nodes responsible for lymphatic drainage of the ipsilateral upper limb (ARM nodes) in breast cancer patients who underwent an axillar lymph node dissection.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients who will undergo ALND in the treatment of breast cancer:
Exclusion criteria
At the time of performing the ALND associate the ARM, injecting between 2-5mL of indocyanine green subcutaneously in the ipsilateral upper extremity at the medial inter-muscular and massaged for 5 min. First, identify the ARM nodes by indocyanine green, then perform conventional axillary lymphadenectomy trying to preserve the ARM nodes. And, in a second time, extract ARM nodes for their individualized anatomopathological study.
Time frame: 1 year
Determinate the percentage of patients who is possible preserve the ARM node during ALND
Time frame: 1 year
Determinate the percentage of metastatic ARM nodes.
Hospital Universitari de Bellvitge
Other
Axillary Reverse Mapping (ARM): Validation of Surgical Tecnique in Breast Cancer Surgery
Acronym: ARM
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